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Thread: Has anyone heard of this center in the US doing stemcells?

  1. #1
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    Has anyone heard of this center in the US doing stemcells?

    https://www.mdstemcells.com/stem-cel...reality-study/


    This location is apparently doing bone marrow derived stemcell treatment under an FDA clinical study. Any thoughts?

  2. #2
    Quote Originally Posted by RyanJ View Post
    https://www.mdstemcells.com/stem-cel...reality-study/


    This location is apparently doing bone marrow derived stemcell treatment under an FDA clinical study. Any thoughts?
    Yes, a couple to start with,

    1. A legitimate patient trial doesn't charge a participant $19,600. for being included.
    2. I cannot get any trial page to come up at the clinical trial.gov site under a call ID of NCT 03225626. (The article doesn't directly link to it).
    3. This is not an "FDA clinical trial".

    DISCLAIMER:

    The stem cell studies available through MD Stem Cells are Institutional Review Board (IRB) approved and FDA compliant. They are open label, non-randomized efficacy studies and no guarantees of specific results or improvements to participating patients are being made. Any medical procedure carries risks as well as potential benefits. The studies have different treatment arms and our investigators assign patients to minimize risk and maximize potential benefit. Depending on the arm chosen the risk of potential complications has been calculated to be from approximately 0.0008% to 5%.
    Last edited by GRAMMY; 11-23-2018 at 04:43 PM.

  3. #3
    Quote Originally Posted by GRAMMY View Post
    2. I cannot get any trial page to come up at the clinical trial.gov site under a call ID of NCT 03225626. (The article doesn't directly link to it).
    I think they made a typo, the trial is https://clinicaltrials.gov/ct2/show/NCT03225625. Or maybe the typo was intentional.

    It's unbelievable that a government site doesn't do more to take these things down - resources I suppose.

  4. #4
    Senior Member lunasicc42's Avatar
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    yes I tried that NCT number with no luck as well but I assumed it was this

    https://clinicaltrials.gov/ct2/show/...jury+vr&rank=1
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  5. #5
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by niallel View Post
    I think they made a typo, the trial is https://clinicaltrials.gov/ct2/show/NCT03225625. Or maybe the typo was intentional.

    It's unbelievable that a government site doesn't do more to take these things down - resources I suppose.
    beat me to it... Posted at about the same time
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  6. #6
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    Hi guys, i think it was a typo.

    ClinicalTrials.gov Identifier: NCT03225625 is the correct trial number.

    They seem to take the patient's own derived bone marrow stem cells and inject them along the spine along the area of injury, along with an IV infusion and an intranasal route so 3 methods of administration. It may be a better alternative than spending money in some foreign country for stem cells.

  7. #7
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    Thanks Grammy for your input. It is greatly appreciated. While it may not be an FDA approved trial, i'm wondering if it should be a safer option since it is in the U.S and all.

  8. #8
    Quote Originally Posted by RyanJ View Post
    Thanks Grammy for your input. It is greatly appreciated. While it may not be an FDA approved trial, i'm wondering if it should be a safer option since it is in the U.S and all.
    You're welcome.

    Well, perhaps "safer" in some aspects compared to overseas clinics but there's still no guarantee or blue ribbon seal. The treatment is being supervised by the company institutional review board. You have no idea who is on this board and it's the company goal to turn a profit of $20k for each person coming through the door. They say they are FDA compliant (whatever that might mean these days). I've seen these stem cell clinics closed when the FDA shows up for an inspection after consumer complaints...

    I would be very wary of these stem cell clinics popping up all over. The best man I know on the job is Paul Knoepfler. He runs the stem cell blog called The Niche. You'll want to read through some of his informative articles on this Florida MD Stem Cells Company.

    Here's the latest post link on it.

    Ryan, I hope this helps with your stem cell questions on the ClinicalTrials.gov Identifier: NCT03225625.
    Last edited by GRAMMY; 11-24-2018 at 01:05 AM.

  9. #9
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    Hi Grammy, thanks again for your genuine knowledge and advice. It is so greatly appreciated. I will definitely read through the link you posted to do more due diligence on my part.
    I am also posting a response I got from the clinic regarding more details of the study. I am going to try to call them as well to see if I can possibly speak to any patients that they may have performed the procedure on. Here is the information they sent me via email.
    This is just more information for anyone to make a better informed decision. Hope it helps!!!



    "We appreciate your interest in stem cell approaches to spinal cord injury. We are recruiting for a study that will evaluate the efficacy of bone marrow derived stem cell (BMSC) treatments in this condition called the Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality (SicExVR) study. You may review at www.clinicaltrials.gov Identifier NCT 03225625. After reviewing this email if you have any questions you may email or can call me at 203-423-9494 during business hours EST (Eastern Standard Time United States ).



    SciExVR is seeking patients with Thoracic or Lumbar level spinal cord injuries resulting in paraplegia / sensory / autonomic dysfunction. If there is a low C spine injury with preservation of some upper limb function, we will look carefully to consider for inclusion.



    If you would like an evaluation please email us the patient name, date of birth, email and cell number, brief history of spinal cord disease or injury including the level of the spinal cord injury and a short summary of any motor, sensory, bladder/bowel deficits. You may then email a recent neurologic exam providing evaluation and diagnosis. We strongly prefer any neurologic exams be sent as a email attachment. However if you or your neurologist wish to fax any examinations please fax to 203-905-6800.

    Once received the exam(s) will be evaluated by our investigator who will review and indicate if he believes the patient falls within the guidelines and could potentially benefit from the treatment. Generally speaking the patients must be able to be moved in a wheelchair in order to be treated at the surgical center we use. You will then be notified by email. Please email or call if you have not heard back from us within 7-10 days.



    The treatment is a transfer of active bone marrow derived adult stem cells to the bilateral paraspinal areas at, superior and inferior to the site of injury. This means the BMSC are injected next to the spinal nerves on both side of the injury, as well as a segment above and a segment below the injury. The remaining BMSC are provided intravenously (in the vein in the arm) and intranasally (within the nose for potential entry through the 5th cranial nerves).
    We are using the American Spinal Cord Injury Association (ASIA) evaluation of Injury Assessment (AIA). If you are accepted and wish to proceed, we will need this assessment performed by your neurologist before the scheduled treatment and then at 1,3,6 and 12 months following treatment and forwarded to us.
    The AIA scores pre and post procedure are absolutely required. Whether a patient feels there is improvement or not, these assessments must be completed to assess any progress,help future patients and allow our group to publish results.
    There are 3 Arms to the study. Arm 1 uses the above BMSC injection approach and then the patient is followed. Arm 2 adds Exoskeletal stimulation if the patient has access or an equivalent physical therapy approach to stimulate the muscles and proprioceptors. Arm 3 adds a virtual reality or equivalent approach to stimulate the premotor and motor cortex of the brain.

    Many years of both pre-clinical (animal models) and clinical (humans) work with stem cells has been done in an attempt to provide functional improvement or repair of the spinal cord injury. Although some progress has been made, the goal of significant improvement remains frustratingly elusive. We do not know if our approach will make any difference to the measurements on the AIA or to a patient's daily life.

    As each patient is different, the informed consent states that results cannot be be guaranteed and that there are small risks of complications from the anesthesia, bone marrow aspiration and treatment. We cannot be predictive of individual patient results and there may be improvement, no improvement or continued deterioration of your spinal cord injury and neurologic status. The SciExVR study is designed to evaluate and allow us to report on the efficacy of this treatment.
    The treatment includes the pre and first post op exams, the stem cell procedure at the licensed surgical center including anesthesia by their board certified anesthesiologists, bone marrow aspiration by our orthopedic surgeon, processing of the bone marrow aspirate to isolate the stem cells using an FDA cleared medical device / CE certified ( Europe) and treatment with your own bone marrow derived adult stem cells by Dr. Silberfarb- our board certified orthopedic surgeon and fellowship trained spine surgeon.


    We have no grant support or investors for this procedure. This is a patient funded open label, non-randomized efficacy study. The cost to participate is USD $19,600.oo. Because this is investigational and CPT codes do not exist, insurance companies will not pay for this treatment.

    All final therapeutic decisions are made by you and our investigator after his evaluation and providing of informed consent.


    It is important that patients NOT be active smokers to participate in the study. In the literature it has been shown that smoking and nicotine inhibit the proliferation, migration and differentiation of the mesenchymal stem cells from the bone marrow. Any improvements from SciExVR will likely be diminished or eliminated by smoking. Therefore we cannot accept patients who have not quit prior to the treatment.




    Travel, hotels, meals and the required pre-op clearance and testing by your medical physician are not included. Arrival would on the weekend just before the treatment ,
    pre-op and informed consent Monday , treatment Tuesday, post-procedure visit Wednesday and Friday. Patients may then travel home. Non-US patients should be mindful of any visa requirements.


    To get more information:

    On the www.clinicaltrials.gov website - search NCT 03225625 or type in "SciExVR " to find the study."



  10. #10
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    Hi Grammy, thanks again for all your great advice and input.
    I did go ahead and look at the link relating to Paul Knoepfler and it seems like he is very one sided when it comes to any type of stem cell treatment. While I do agree that with all stem cell treatments, due diligence should definitely be performed.
    I actually emailed the medical staff at mdstemcells.com and they responded with this email.
    Just additional information for anyone that wants it regarding the study.

    "We appreciate your interest in stem cell approaches to spinal cord injury. We are recruiting for a study that will evaluate the efficacy of bone marrow derived stem cell (BMSC) treatments in this condition called the Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality (SicExVR) study. You may review at www.clinicaltrials.gov Identifier NCT 03225625. After reviewing this email if you have any questions you may email or can call me at 203-423-9494 during business hours EST (Eastern Standard Time United States ).

    SciExVR is seeking patients with Thoracic or Lumbar level spinal cord injuries resulting in paraplegia / sensory / autonomic dysfunction. If there is a low C spine injury with preservation of some upper limb function, we will look carefully to consider for inclusion.



    If you would like an evaluation please email us the patient name, date of birth, email and cell number, brief history of spinal cord disease or injury including the level of the spinal cord injury and a short summary of any motor, sensory, bladder/bowel deficits. You may then email a recent neurologic exam providing evaluation and diagnosis. We strongly prefer any neurologic exams be sent as a email attachment. However if you or your neurologist wish to fax any examinations please fax to 203-905-6800.

    Once received the exam(s) will be evaluated by our investigator who will review and indicate if he believes the patient falls within the guidelines and could potentially benefit from the treatment. Generally speaking the patients must be able to be moved in a wheelchair in order to be treated at the surgical center we use. You will then be notified by email. Please email or call if you have not heard back from us within 7-10 days.



    The treatment is a transfer of active bone marrow derived adult stem cells to the bilateral paraspinal areas at, superior and inferior to the site of injury. This means the BMSC are injected next to the spinal nerves on both side of the injury, as well as a segment above and a segment below the injury. The remaining BMSC are provided intravenously (in the vein in the arm) and intranasally (within the nose for potential entry through the 5th cranial nerves).
    We are using the American Spinal Cord Injury Association (ASIA) evaluation of Injury Assessment (AIA). If you are accepted and wish to proceed, we will need this assessment performed by your neurologist before the scheduled treatment and then at 1,3,6 and 12 months following treatment and forwarded to us.
    The AIA scores pre and post procedure are absolutely required. Whether a patient feels there is improvement or not, these assessments must be completed to assess any progress,help future patients and allow our group to publish results.
    There are 3 Arms to the study. Arm 1 uses the above BMSC injection approach and then the patient is followed. Arm 2 adds Exoskeletal stimulation if the patient has access or an equivalent physical therapy approach to stimulate the muscles and proprioceptors. Arm 3 adds a virtual reality or equivalent approach to stimulate the premotor and motor cortex of the brain.

    Many years of both pre-clinical (animal models) and clinical (humans) work with stem cells has been done in an attempt to provide functional improvement or repair of the spinal cord injury. Although some progress has been made, the goal of significant improvement remains frustratingly elusive. We do not know if our approach will make any difference to the measurements on the AIA or to a patient's daily life.

    As each patient is different, the informed consent states that results cannot be be guaranteed and that there are small risks of complications from the anesthesia, bone marrow aspiration and treatment. We cannot be predictive of individual patient results and there may be improvement, no improvement or continued deterioration of your spinal cord injury and neurologic status. The SciExVR study is designed to evaluate and allow us to report on the efficacy of this treatment.
    The treatment includes the pre and first post op exams, the stem cell procedure at the licensed surgical center including anesthesia by their board certified anesthesiologists, bone marrow aspiration by our orthopedic surgeon, processing of the bone marrow aspirate to isolate the stem cells using an FDA cleared medical device / CE certified ( Europe) and treatment with your own bone marrow derived adult stem cells by Dr. Silberfarb- our board certified orthopedic surgeon and fellowship trained spine surgeon.


    We have no grant support or investors for this procedure. This is a patient funded open label, non-randomized efficacy study. The cost to participate is USD $19,600.oo. Because this is investigational and CPT codes do not exist, insurance companies will not pay for this treatment.

    All final therapeutic decisions are made by you and our investigator after his evaluation and providing of informed consent.


    It is important that patients NOT be active smokers to participate in the study. In the literature it has been shown that smoking and nicotine inhibit the proliferation, migration and differentiation of the mesenchymal stem cells from the bone marrow. Any improvements from SciExVR will likely be diminished or eliminated by smoking. Therefore we cannot accept patients who have not quit prior to the treatment.




    Travel, hotels, meals and the required pre-op clearance and testing by your medical physician are not included. Arrival would on the weekend just before the treatment ,
    pre-op and informed consent Monday , treatment Tuesday, post-procedure visit Wednesday and Friday. Patients may then travel home. Non-US patients should be mindful of any visa requirements.


    To get more information:

    On the www.clinicaltrials.gov website - search NCT 03225625 or type in "SciExVR " to find the study."



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